MedInsight

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  • FDA and EU expand Mutual Recognition Agreement, again!

    FDA and EU expand Mutual Recognition Agreement, again!

    In 2017, the FDA initiated MRAs with EU and UK, for human drugs. On May 30th, the FDA once again signed an MRA, with 16 EU countries, this time concerning veterinary drugs.
  • Impact of European AI Act on Medical Devices

    Impact of European AI Act on Medical Devices

    EU AI Act is to be the world's first AI law. European Parliament passed the draft on June 14. However, it faced opposition from industry organizations like MedTech Europe, the Confederation of European Business, and Team-NB (European Association for Medical Devices Notified Bodies).
  • Decoding QMSR: FDA QMSR & ISO 13485 Harmony

    Decoding QMSR: FDA QMSR & ISO 13485 Harmony

    QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.
  • EU MDR transition period extended to 12/2028 - Hangzhou MedAsia

    EU MDR Transition Extended to 12/2028

    With Medasia, you can confidently bring safe and effective medical devices to market while staying up to date with the latest MDR guidelines. Don't risk non-compliance – secure your MDR certification today with Medasia's future-proof homecare products.
  • EU's USB-C Regulation Affects Healthcare Products - Hangzhou MedAsia

    EU's USB-C Regulation Affects Healthcare

    By the end of 2024, all electronic devices sold in the EU will have to be equipped with a USB Type-C charging port. While the impact of the new regulations on the home health product industry remains to be seen, it is clear that compliance with the universal charging port requirements will be necessary for manufacturers operating within the EU.
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